Cerebrovascular Hemodynamics in Patients With ARDS.

Completed

• Conditions: ARDS
• Interventions: Diagnostic Test: Near-infrared spectroscopy-based assessement of cerebral autoregulation.

• Registration Number: NCT03949738
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

The acute respiratory distress syndrome (ARDS) is a life-threatening disease with functional impairment of the lung. It is characterized by an excessive inflammatory response of lung tissue, capillaries, and blood vessels and is associated with high mortality. Patients who survive the acute phase of this critical disease often suffer from long-term physical, psychological, and mental sequelae, as well as persistent cognitive deficits.

In healthy individuals, autoregulatory mechanisms of the intracranial blood vessels keep blood supply to the brain independent of fluctuations in systemic blood pressure. In the case of a serious illness, these mechanisms of autoregulation may be impaired, which may favor cerebral hypoperfusion. Impairment of cerebrovascular hemodynamics can lead to neuronal damage in short and long term.

The aim of this project is to investigate cerebrovascular autoregulation in adult patients with ARDS and to evaluate the cognitive outcome at 3, 6 and 12 months after discharge from the intensive care unit.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-14
• Primary Completion: 2019-11-30
• Study Completion: 2020-11-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-24
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• ARDS

Exclusion Criteria

• Pre-existing neurological diseases with known intracranial pathology
• Cerebrovascular disorders, including hemodynamically relevant extracranial vascular stenoses

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult patients with ARDS	Near-infrared spectroscopy-based assessement of cerebral autoregulation.	Adults patients fulfilling the Berlin criteria for ARDS

Primary Outcome Measures

Name	Time	Method
COx	Assessment for 60 minutes per day during the acute phase of ARDS (maximum 14 days after ARDS onset).	Cerebral Oximetry Index (COx) as a moving correlation between arterial blood pressure and cerebral oximetry with a range from -1 to +1. A COx above 0.3 is defined as impaired cerebrovascular autoregulation. The minutes with COX above 0.3 will be assessed.

Secondary Outcome Measures

Name	Time	Method
Cognitive Failures Questionnaire (CFQ)	3, 6 and 12 months after discharge from ICU.	The Cognitive Failures Questionnaire is a self-report scale used to assess forgetfulness or inattention. It contains 25 items that are rated on a 5-point Likert scale, resulting in a total CFQ score varying from 0 to 100, with higher scores indicating more cognitive failures.
The Short Form (36) Health Survey (SF-36)	3, 6 and 12 months after discharge from ICU.	The SF-36 is a questionnaire used to assess patient-reported health. It contains eight health-related topics. Each topic is rated on a scale from 0 to 100 with lower scores representing more disability.

Trial Locations

Locations (1)

Universitätskrankenhaus Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany